Safety, immunogenicity and effect on viral rebound of HTI vaccines combined with a TLR7 agonist in early-treated HIV-1 infection: a randomized, placebo-controlled phase 2a trial

Building on results from the AELIX-002 trial with HIVACAT T-cell immunogen (HTI)-based vaccines, the AELIX-003 (NCT04364035) trial tested the safety of the combination of ChAdOx1.HTI (C) and MVA.HTI (M), with the TLR7 agonist vesatolimod (VES), in a double-blind, placebo-controlled, randomized clini...

Full description

Bibliographic Details
Authors: Bailón, Lucia, Moltó, José, Curran, Adrian, Cadiñanos Loidi, Julen, López Bernaldo de Quirós, Juan Carlos, Santos, Ignacio de los, Ambrosioni, Juan, Imaz, Arkaitz, Benet, Susana, Suanzes, Paula, Navarro, Jordi, González García, Juan, Busca, Carmen, Pérez Latorre, Leire, Berenguer, Juan, García Fraile Fraile, Lucio Jesús, Mejía Abril, Gina, Miró Meda, José M. (José María), 1956-, Scévola, Sofía, Moreno Guillén, Santiago, Domingo, Pere (Domingo Pedrol), Tian, Yuan, Frankot, Michelle, Lim, Daina, Cai, Yanhui, Vendrame, Elena, Guo, Susan, Wallin, Jeffrey J., Geleziunas, Romas, SenGupta, Devi, Alarcón Soto, Yovaninna, Leal Cortijo, Isabel, Aranguen Ibáñez, Alvaro, García García, Margarida, Mcgowan, Ian, Brander, Christian, Arribas, Jose Ramón, Mothe, Beatriz, The Aelix-003 Study Group
Format: article
Status:Published version
Publication Date:2025
Country:España
Institution:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repository:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:2445/221361
Online Access:https://hdl.handle.net/2445/221361
Access Level:Open access
Keyword:Antiretrovirals
VIH (Virus)
Assaigs clínics
Antiretroviral agents
HIV (Viruses)
Clinical trials
Description
Summary:Building on results from the AELIX-002 trial with HIVACAT T-cell immunogen (HTI)-based vaccines, the AELIX-003 (NCT04364035) trial tested the safety of the combination of ChAdOx1.HTI (C) and MVA.HTI (M), with the TLR7 agonist vesatolimod (VES), in a double-blind, placebo-controlled, randomized clinical trial in 50 virally suppressed early-treated men with HIV-1 infection. Secondary objectives included immunogenicity and effects on viral rebound kinetics during a 24-week antiretroviral treatment interruption (ATI). The most common treatment-related adverse events were mild-to-moderate injection-site pain, influenza-like illness, headache, and fatigue. Strong, broad, and HTI-focused T-cell responses were induced by vaccination. All participants experienced viral rebound in ATI; 33.3% and 23.5% (P = 0.4494) of CCMM + VES and placebo recipients, respectively, remained off antiretroviral therapy for 24 weeks. Post hoc analysis confirmed a correlation between levels of HTI-specific T cells and prolonged time off antiretroviral therapy. The combination of HTI vaccines and VES was safe and elicited robust T-cell responses.

Similar Items